Study on FDG-PET-Guided Radiation Therapy for Treating Metastatic Hormone Sensitive Prostate Cancer (The PRTY Trial)

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06244004

Provider View

This clinical trial is exploring whether using FDG-PET scans to guide radiation therapy, in addition to standard treatments, can better treat prostate cancer that has spread and is sensitive to hormone therapy.

Patient Parameters

Program Overview

This study is testing if adding radiation therapy, guided by FDG-PET scans, to standard treatments can improve outcomes for patients with prostate cancer that has spread and responds to hormone therapy. Prostate cancer is a leading cause of cancer death among men, but recent advances have improved survival for those with metastatic hormone-sensitive prostate cancer. The trial aims to see if targeting active cancer sites identified by FDG-PET scans with radiation can delay cancer progression and extend life more effectively than standard treatments alone.

Description

The study is divided into two groups based on the type of treatment patients are receiving.

Cohort 1 includes patients undergoing chemotherapy. These patients will have an FDG-PET scan after 6 months of standard chemotherapy and hormone therapy. If the scan shows active cancer, they will be randomly assigned to either continue with standard treatment alone or add radiation therapy to up to 5 cancer sites. Patients without active cancer on the scan will continue with standard treatment.

Cohort 2 includes patients not receiving chemotherapy. These patients will have an FDG-PET scan after 6 months of hormone therapy. If the scan shows active cancer, they will be randomly assigned to either continue with standard treatment alone or add radiation therapy to up to 5 cancer sites. Patients without active cancer on the scan will continue with standard treatment.

The study will follow patients for up to 36 months, with regular check-ups to monitor their health and cancer progression.

Eligibility Criteria

Inclusion Criteria

  • Must have prostate cancer that has spread, as shown by imaging tests.
  • Must be 18 years or older.
  • Must be in good enough health to participate, with a performance status score of 0-3.
  • For Cohort 1: Must be planning or currently receiving chemotherapy and hormone therapy.
  • For Cohort 2: Must be planning or currently receiving hormone therapy without chemotherapy.
  • Must have adequate blood cell counts and organ function.
  • Must be able to undergo FDG-PET scans and radiation therapy.
  • Must have a life expectancy of at least 6 months.
  • Must understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • Prostate cancer that is resistant to hormone therapy.
  • Started hormone therapy more than a year ago.
  • Started additional treatments beyond hormone therapy more than 30 weeks ago.
  • Known allergy to imaging contrast that cannot be managed with pre-medications.
  • Participating in another clinical trial that conflicts with this study.

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